Market Trends– category –
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FDA Personalized Gene Therapy: Draft Guidance for Rare Diseases
BioPharma Dive (via Yahoo News) USA Overview The FDA has proposed a new regulatory framework for personalized gene therapies to accelerate access for rare disease treatments. The plan allows drugmakers to secure subsequent clearances for... -
iPS Cell Therapy: Manufacturing Roadmap and Cost Reduction Goals
Toyo Keizai Online Japan Overview Two iPS cell-derived products for Parkinson's disease and severe heart failure received conditional and time-limited approval from Japan's Ministry of Health, Labour and Welfare in March 2026. To enable ... -
Botanical EVs: Scaling Commercial Production via World Exosome Center
WEC USA Overview The World Exosome Center provides an industrial infrastructure to transition botanical extracellular vesicles (EVs) from laboratory isolation to repeatable B2B supply. By implementing stabilization workflows and standard... -
NIST CHO Cell Protocols: 2026 standards for reproducibility
National Institute of Standards and Technology (NIST) USA Overview The National Institute of Standards and Technology (NIST) has released an integrated upstream workflow protocol (NIST SP 1200-32) for the standardized NISTCHO cell system... -
Multifors 3: INFORS HT 23-day perfusion culture specs
INFORS HT Switzerland Overview INFORS HT has published an application note detailing the successful 23-day long-term perfusion culture of NIST CHO cells using its Multifors 3 benchtop bioreactor. The study proves the Multifors 3's suitab... -
FDA vs. EMA: CGT manufacturing GMP specs and 2026 differences
Rhizome AI USA Overview The FDA and EMA employ distinct strategies for manufacturing controls and GMP requirements for cell and gene therapy (CGT) products at the Investigational New Drug (IND)/Clinical Trial Application (CTA) stage. The... -
Viral Vectors: Wave-mixed vs stirred-tank bioreactor specs
BioProcess Tools USA Overview A comparative analysis of bioreactor platforms for viral vector manufacturing reveals distinct advantages: wave-mixed bioreactors, offering low shear, are ideal for shear-sensitive lentivirus, T-cell expansi... -
I Peace: Clinical-grade iPSC mass production specs for 2026
BioInformant USA Overview I Peace has developed a fully-closed automated manufacturing system capable of mass-producing clinical-grade induced pluripotent stem cell (iPSC) lines, successfully meeting stringent FDA and PMDA safety standar... -
Lonza Expands US Manufacturing with New Spray Drying Facility; Samsung Biologics Secures $262M European CDMO Deal
Endpoints News Switzerland, South Korea, USA Overview Lonza announced a significant expansion of its U.S. manufacturing capabilities with a new commercial spray drying facility in Bend, Oregon, projected for completion by 2029 and creati... -
BIANCA CLINIC Pioneers Regenerative Medicine in Japan with Autologous Adipose Stem Cells and Exosome Therapy under Strict Regulatory Compliance
BIANCA CLINIC Japan Overview BIANCA CLINIC in Tokyo is advancing regenerative medicine by offering exosome therapy, purified stem cell culture supernatant, and autologous adipose-derived stem cell therapy, all strictly compliant with Jap...
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